Primary Device ID | B756SMT0010 |
NIH Device Record Key | 0bf40051-6daf-47cb-9fab-3ec849d59827 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Shukla Knee S9KNEE |
Version Model Number | SMT001 |
Company DUNS | 159009294 |
Company Name | Shukla Medical |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com | |
Phone | +1-727-626-2770 |
CS@ShuklaMedical.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B756SMT0010 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
[B756SMT0010]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-07-21 |
Device Publish Date | 2021-07-13 |
B756SXT0020 | Extractor Assy, Femoral Component |
B756SXT0010 | Extractor Assembly, Tibial Component |
B756SBD0030 | Movable Jaw (sub-assembly) |
B756STP0480 | Jaw Tip, Knee Tibial Extractor, Replaceable |
B756SSH0070 | Connector Shaft for Strike Plate |
B756SOS001100 | Osteotome Assy, Z Shaped, 3/4" Reach, .313" Wide |
B756SOS001090 | Osteotome Assy, Z Shaped, 1/2" Reach, .313" Wide |
B756SOS001080 | Osteotome Assy, Retrograde, 3/4" Reach, .500" Wide |
B756SOS001070 | Osteotome Assy, Retrograde, 1/2" Reach, .500" Wide |
B756SOS001060 | Osteotome Assy, Retrograde, 3/4" Reach, .313" Wide |
B756SOS001050 | Osteotome Assy, Retrograde, 1/2" Reach, .313" Wide |
B756SMT0010 | Mallet Assembly, Grooved |
B756SIN0010 | Handle Assy, Osteotome, Twist Lock |
B756SCA1010 | Case & Tray, Knee System |
B756SBD0080 | Strike Plate, Assy, Frame (C-Frame) |